NCT07197996Completed
The RETRAIN Trial Phase 2
MonitoRing the Effect of Intermittent Pneumatic Compression and TRAnscutaneous Functional electrIcal Stimulation of the Common Peroneal Nerve Using the Geko® Device on Cerebral Haemodynamics in Patients With Ischaemic Strokes (The RETRAIN Trial Phase 2)
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
Ischaemic strokes, caused by a disruption in the brain's blood supply, are the second leading cause of death and disability in the United Kingdom. This single-center prospective randomised study aims to measure cerebral blood flow and oxygen delivery in patients who have recently suffered an ischaemic stroke and are using either the geko® neuromuscular electrostimulation device or an intermittent pneumatic compression (IPC) device as part of their routine clinical care. The geko® device stimulates a nerve in the lower leg, inducing muscle contractions that enhance blood circulation. The IPC device applies controlled external pressure through compressed air and a pump, cyclically inflating and deflating chambers in a sleeve worn on the leg. This mimics the action of calf muscles to promote blood flow. The primary objective of this study is to assess the effect of the geko® and IPC devices on cerebral blood flow in stroke patients, specifically during the hyperacute phase (within 36 hours) following an ischaemic stroke. Both devices will be used as part of standard care for VTE prevention. Cerebral blood flow will be measured using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 25 Sept 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 26 May 2026
- Lead sponsor
- Firstkind Ltd
- Diseases
- Stroke
- NCT number
- NCT07197996
What you commit to
- Study type: Interventional
- Participants enrolled: 53
- From 1 Jul 2025 to the primary completion date, 26 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically apparent deep vein thrombosis at screening
- Contraindications for the use of the geko™ device
- Allergy to hydrogel constituents
- Contraindications to IPC
- Severe peripheral vascular disease
- Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion)
- Severe oedema
- Leg deformities making appropriate fitting impossible
- Symptomatic congestive cardiac failure of NYHA class IV (symptoms of heart failure at rest, any physical activity causing further discomfort).
- Patients must not have a current coronavirus (COVID-19) infection
Other
- Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee.
- Absence of a transient ischaemic attack (TIA).
- Patient is expected to require palliative care within 14 days
- No response to the geko® device i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
- Single or double leg amputations.
- Participation in any other clinical trial
Who the study is looking for
- Adult over 18
- Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
- Within 36 hours of symptom onset.
- Unable to stand or mobilise without assistance.
- No intracerebral haemorrhage as ruled out by computerised tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Countess of Chester Hospital Coordinator of this site? Confirm its status | Chester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.